Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Dalton to Start GMP Mfg. for Inhalation Drug Candidate | Contract Pharma

What are you searching for?

Sign in
Breaking News

Dalton to Start GMP Mfg. for Inhalation Drug Candidate

Arch Biopartners expects AB569 to enter phase I later this year

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Dalton Pharma Services has launched the good manufacturing practice (GMP) campaign for Arch Biopartners’ AB569, an inhalation drug candidate for treating antibiotic-resistant bacterial infections in the lungs.

Dalton will be responsible for the GMP preparation and filling of AB569 into glass vials. These vials will then form part of the clinical kits required to support the phase I safety trial for AB569 at the Cincinnati Veterans Affairs Medical Center (CVAMC) later this year.

Catalent Inhalation, a division of Catalent Pharma Solutions, (www.catalent.com), previously completed the initial stability and formulation studies for AB569, which were both important production milestones in preparing a GMP pharmaceutical product for human trials and eventual drug approval by the FDA and other health authorities.

Catalent will continue to be involved in the final testing of the GMP supply of AB569 once the vial filling is completed by Dalton to enable the release of the final drug product. 

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics